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FDA 510(k)

MEGAPULSE II

K-Number: K973732 · 1998-01-23

ApplicantPti
Decision Date1998-01-23
Product CodeIMJ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MEGAPULSE II is the device name listed in this FDA 510(k) record. The listed applicant is Pti. It received FDA 510(k) clearance on 1998-01-23 under 510(k) number K973732. The device is classified under product code IMJ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEGAPULSE II?

MEGAPULSE II is a medical device that received FDA 510(k) clearance on 1998-01-23. The listed applicant is Pti. The 510(k) number is K973732.

When did MEGAPULSE II receive FDA 510(k) clearance?

MEGAPULSE II received FDA 510(k) clearance on 1998-01-23, under 510(k) number K973732.

Who is the listed applicant for MEGAPULSE II?

The FDA 510(k) record lists Pti as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEGAPULSE II?

The FDA product code for MEGAPULSE II is IMJ.

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Related Devices (Code: IMJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252963BTL-899TTBTL Industries, Inc.K250376ViVYViatherm Therapeutics, LLCK243112Curapuls 670Enraf-Nonius, B.V.K223620Reprieve by RegenesisTMRegenesis Biomedical, Inc.K182363BTL-703BTL Industries, Inc.K173300ViaTherm BOOSTViatherm Therapeutics, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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